On September 23, 2013, thirty five ME/CFS experts sent an open letter to HHS Secretary Sebelius informing her that they have come to a consensus about the use of the Canadian Consensus Criteria (CCC) as the official disease definition and urging HHS to also adopt the CCC as the sole case definition as well as to abandon efforts to engage the Institute of Medicine( IOM)—an organization completely inexperienced in developing disease definitions and in the disease itself—to create a case definition. Secretary Sebelius has shown the experts no respect at all and has, in fact, not even found it necessary to respond to them, let alone heed their advice. Yesterday, the experts doubled down and added sixteen more signatures to the letter.
As a—somewhat insignificant—side note, this calls into question PANDORA’s statement that “at least one other [expert besides Dr. Batemen told them] privately that he has changed his position” blatantly wrong and as well as their reasons for trying to create doubt about the experts’ resolve.
The additional experts are:
Lily Chu, MD, MSHS
Todd E. Davenport, PT, DPT, OCS
Kenneth J. Friedman, PhD
Betsy Keller, PhD, FACSM
Konstance Knox, PhD
Malcolm S. Schwartz, DO, FAOCP
Julian M. Stewart, MD, PhD
J. Mark VanNess, PhD
Alison C. Bested, MD, FRCPC
Nicoletta Carlo-Stella, MD, PhD
Øystein Fluge, MD, PhD
Malcolm Hooper, PhD, BPharm, MRIC, CChem
Olav Mella, MD, PhD
Kunihisa Miwa, MD, PhD
Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH
Eleanor Stein, MD, FRCP(C)
The experts published an updated letter:
An Open Letter to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services
Original Letter – September 23, 2013
Update with additional signatures – October 25, 2013
Dear Secretary Sebelius,
We are writing as biomedical researchers and clinicians with expertise in the disease of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to inform you that we have reached a consensus on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for this disease.
The 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda definition, was the primary case definition for ME/CFS for almost two decades. However, in recent years expert researchers and clinicians have increasingly used the CCC, as they have recognized that the CCC is a more scientifically accurate description of the disease.
The CCC was developed by an international group of researchers and clinicians with significant expertise in ME research and treatment, and was published in a peer-reviewed journal in 2003 (Carruthers et al, Journal of Chronic Fatigue Syndrome, 2003). Unlike the Fukuda definition, the more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of research. For example, the CCC requires the symptom of post-exertional malaise (PEM), which researchers, clinicians, and patients consider a hallmark of the disease, and which is not a mandatory symptom under the Fukuda definition. The CCC was endorsed in the Primer for Clinical Practitioners published by the International Association of Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFSME). This organization is the major international professional organization concerned with research and patient care in ME/CFS.
The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care. This step will facilitate our efforts to define the biomarkers, which will be used to further refine the case definition in the future.
We strongly urge the Department of Health and Human Services (HHS) to follow our lead by using the CCC as the sole case definition for ME/CFS in all of the Department’s activities related to this disease.
In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.
ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste. We believe that our consensus decision on a case definition for this disease will jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients. We look forward to this accelerated progress and stand ready to work with you to increase scientific understanding of the pathophysiology of this disease, educate medical professionals, develop more effective treatments, and eventually find a cure.
Sincerely,
United States Signatories
Dharam V. Ablashi, DVN, MS, Dip Bact. Scientific Director of HHV-6 Foundation Co-founder of IACFS/ME
Santa Barbara, CaliforniaDavid S. Bell, MD, FAAP
Researcher and Clinician
Associate Professor of Pediatrics State University of New York at Buffalo Lyndonville, New YorkGordon Broderick, PhD
Professor, Center for Psychological Studies Director, Clinical Systems Biology Lab Institute for Neuro Immune Medicine,
Nova Southeastern University
Fort Lauderdale, FloridaPaul R. Cheney, MD, PhD Director, The Cheney Clinic, PA Asheville, North Carolina
John K.S. Chia, MD Researcher and Clinician President, EV Med Research Lomita, California
Lily Chu, MD, MSHS (Added 10/25/2013) Independent Researcher
Burlingame, CaliforniaTodd E. Davenport, PT, DPT, OCS (Added 10/25/2013) Associate Professor, Physical Therapy
University of the Pacific
Stockton, CaliforniaKenny L. De Meirleir, MD, PhD
Professor Emeritus Physiology and Medicine (Vrije Universiteit Brussel) Medical Director, Whittemore-Peterson Institute
University of Nevada
Reno, NevadaDerek Enlander, MD, MRCS, LRCP
Attending Physician
Mount Sinai Medical Center, New York
ME CFS Center, Mount Sinai School of Medicine New York, New YorkMary Ann Fletcher, PhD
Schemel Professor of NeuroImmune Medicine Institute for Neuro Immune Medicine
Nova Southeastern University
Fort Lauderdale, FloridaKenneth J. Friedman, PhD (Added 10/25/2013)
Associate Professor of Pharmacology and Physiology, New Jersey Medical School (retired) Research Associate, Green Mountain College
Adjunct Instructor, Castleton State College
Pawlet, VermontRonald Glaser, PhD, FABMR
Director, Institute for Behavioral Medicine Research
Kathryn & Gilbert Mitchell Chair in Medicine
College of Medicine – Distinguished Professor
Professor, Molecular Virology, Immunology and Medical Genetics
Professor, Internal Medicine
Professor, Division of Environment Health Sciences, College of Public Health Institute for Behavioral Medicine Research
Columbus, OhioMaureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics Cornell University
Ithaca, New YorkLeonard A. Jason, PhD Professor of Psychology DePaul University Chicago, Illinois
Betsy Keller, PhD, FACSM (Added 10/25/2013)
Professor, Department of Exercise & Sport Sciences, Ithaca College Ithaca, New YorkNancy Klimas, MD
Director, Institute for Neuro Immune Medicine Professor, Nova Southeastern University
Fort Lauderdale, FloridaKonstance Knox, PhD (Added 10/25/2013) Director of Research, Coppe Healthcare Solutions Wisconsin Viral Research Group
Waukesha, WisconsinGudrun Lange, PhD
Clinical Neuropsychologist
Professor, Rutgers New Jersey Medical School Newark, New JerseyA. Martin Lerner, MD, MACP
Professor, Infectious Diseases
Oakland University William Beaumont School of Medicine
Emeritus Director, Infectious Diseases, Wayne State University School of Medicine Master, American College of Physicians
Reviewer, Viral Diseases, Medical Letter
Beverly Hills, MichiganSusan Levine, MD
Researcher and Clinician, Private Practice New York, New York
Visiting Fellow, Cornell University
Ithaca, New YorkAlan R. Light, PhD
Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy University of Utah
Salt Lake City, UtahKathleen C. Light, PhD
Researcher
Professor, Department of Anesthesiology University of Utah School of Medicine Salt Lake City, UtahPeter G. Medveczky, MD
Professor, Department of Molecular Medicine College of Medicine
University of South Florida
Tampa, FloridaJudy A. Mikovits, PhD Researcher, MAR Consulting, LLC Carlsbad, California
Jose G. Montoya, MD, FACP, FIDSA
Professor of Medicine
Division of Infectious Diseases and Geographic Medicine Stanford University School of Medicine
Stanford, CaliforniaJames M. Oleske, MD, MPH
François-Xavier Bagnoud Professor of Pediatrics
Director, Division of Pediatrics Allergy, Immunology & Infectious Diseases Department of Pediatrics, Rutgers New Jersey Medical School
Newark, New JerseyMartin L. Pall, PhD
Professor Emeritus of Biochemistry and Basic Medical Sciences Washington State University
Portland, OregonDaniel Peterson, MD
Founder and President of Sierra Internal Medicine Incline Village, NevadaRichard Podell, MD, MPH
Clinical Professor, Department of Family Medicine UMDNJ Robert Wood Johnson Medical School New Brunswick, New JerseyIrma Rey, MD
Clinician
Institute for Neuro Immune Medicine Nova Southeastern University
Fort Lauderdale, FloridaMalcolm S. Schwartz, DO, FAOCP (Added 10/25/2013)
Clinical Associate Professor of Pediatrics, Drexel University College of Medicine Philadelphia, Pennsylvania
Pediatric Endocrine LLC.
Long Branch, New JerseyChristopher R. Snell, PhD
Professor, Health, Exercise and Sport Sciences University of the Pacific
Stockton, CaliforniaConnie Sol, MS, PhDc
Clinical Exercise Physiologist, Institute for Neuro Immune Medicine Nova Southeastern University
Fort Lauderdale, FloridaStaci Stevens, MA
Exercise Physiologist Founder, Workwell Foundation Ripon, CaliforniaJulian M. Stewart, MD, PhD (Added 10/25/2013)
Director, Center for Hypotension, Associate Chairman of Pediatrics, Professor of Pediatrics,Physiology and Medicine New York Medical College Vahalla, New York
Rosemary A. Underhill, MB BS, MRCOG, FRCSE Independent Researcher
Palm Coast, FloridaJ. Mark VanNess, PhD (Added 10/25/2013)
Associate Professor, Department Health, Exercise and Sport Sciences – College of Pacific Adjunct Professor, Department of Bioengineering – College of Computer Sciences andEngineering University of the Pacific Stockton, California
Marshall V. Williams, PhD
Professor, Departments of Molecular Virology, Immunology and Medical Genetics; Microbiology The Ohio State University
Columbus, OhioInternational Signatories
Alison C. Bested, MD, FRCPC (Added 10/25/2013)
Medical Director, Complex Chronic Diseases Program
British Columbia Women’s Hospital and Health Centre
Clinical Associate Professor, Faculty of Medicine, University of British Columbia Vancouver, British Columbia, CanadaNicoletta Carlo-Stella, MD, PhD (Added 10/25/2013) Clinician
Nazzani Studio
Pavia, ItalyBirgitta Evengard, MD, PhD
Professor, Division Infectious Diseases Umea University
Umea, SwedenØystein Fluge, MD, PhD (Added 10/25/2013) Consultant in Oncology, Department of Oncology Haukeland University Hospital
Bergen, Norway
Malcolm Hooper, PhD, BPharm, MRIC, CChem (Added 10/25/2013) Emeritus Professor of Medicinal Chemistry, University of Sunderland Sunderland, Tyne and Wear, United Kingdom
Sonya Marshall-Gradisnik, PhD
Director, National Centre for Neuroimmunology and Emerging Diseases Griffith Health Institute
Professor, Griffith University Parklands Gold Coast
Queensland, AustraliaOlav Mella, MD, PhD (Added 10/25/2013) Professor, Director, Department of Oncology Haukeland University Hospital
Bergen, NorwayKunihisa Miwa, MD, PhD (Added 10/25/2013) Director, Miwa Naika Clinic
Toyama City, Toyama Prefecture, JapanCharles Shepherd, MB BS
Honorary Medical Adviser to the ME Association London, United KingdomNigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH Pediatrician
County Durham, United KingdomEleanor Stein, MD, FRCP(C) (Added 10/25/2013) Psychiatrist
Assistant Clinical Professor, University of Calgary Calgary, Alberta, CanadaRosamund Vallings, MNZM, MB BS IACFS/ME Secretary
Clinician, Howick Health and Medical Clinic Auckland, New ZealandCc:
(Added 10/25/2013)
Dr. Howard Koh, Assistant Secretary for Health
Dr. Richard Kronick, Director, Agency for Healthcare Research and Quality
Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention
Ms. Marilyn Tavenner, Administrator, Centers for Medicare and Medicaid Services Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration
Dr. Mary Wakefield, Administrator, Health Resources and Services Administration Dr. Francis Collins, Director, National Institutes of Health
Ms. Carolyn W. Colvin, Commissioner, Social Security Administration
Thoughts About M.E. 
Thank you so much, Jeanette, for getting this most important information out to us! This is, indeed, exciting and positive news with the added 16 researchers/experts signatories speaking up to HHS with the already 35 — speaking up for justice in this deplorable saga of ‘keeping ME/CFS under wraps’–as the disease ruins and continues to ruin millions of our lives world-wide!!!!
If the ‘powers that be’ do not take heed . . . they really ARE exposing themselves as to being CONTRARY to getting to the real and scientific answers behind a very debilitating and complex disease called ME/CFS that millions of us world wide have been stricken with and suffer from on an ongoing life-altering/restricting daily basis.
Thanks for letting us know Jeanette. So good to see an additional 16 signatories to the open letter.
thanks Jeannette! another good writing piece!
Thanks Jeanette! This is great news!
Good news! I hope it makes a dent in the ridiculous IOM schema. If only this money would go towards necessary research. Why the government at this time of austerity would fund this project is beyond me, unless the goal is to get a case definition that would allow governmental disability and medical programs to cut back on funds and services to people with ME/CFS, as well as private companies, too.
To clarify, it is certainly possible that experts privately told PANDORA that they changed their minds and then changed it back. But does that seem likely? Not exactly. Therefore, although I don’t want to overstate my point, my question very much still stands.
It does not seem likely–perhaps another source intimated there was going to be a change (of minds). Who knows.
This is most welcome news! I really needed this! Thank you so much to all the signatories!!
To those who say, “let’s just lie down and accept that this contract is going forward”- more signs that we can get this contract cancelled!
HHS has successful oppressed us for 30 years. some would say this is proof that their plans always work and we can’t stop them. But every attempt to abuse people always works… until it doesn’t. There comes a point of critical mass, a turning point where the oppressors are forced to stop because the pressure on them becomes too intense.
This really looks like the turning point for us; our Rosa Parks moment where we say “No, we won’t go to the back of the bus any more!” that finally sparks a huge change. Never before have our experts supported us before other than one at a time here and there. NOW FIFTY SO FAR have come together to support us and say “NO MORE.”
We have momentum now (see also that Canary in the Coal Mine has already raised $73K in just four days and there are three other ME docs in the works) This is the turning point. We can push this boulder over the hill now. Lets ALL get together and give it all, that our health will permit. NOW is the time to call in your favors and also just plain beg your friends and family to support us in crushing this contract. This is what I am doing and if we all do it, we will exponentially increase our force and become unstoppable! The AIDS patients did it. Let us do it! If not now, when?
Agreed, Justin! I also think it would be great to “tip off” someone in the political press about our collective push back against HHS. The controversy will help our case and add pressure on Sebelius…at least to respond.
Agreed. I am too busy at the moment.
I, Dr John L Whiting of Brisbane, Australia, hereby add my name to the list of ME / CFS expert signatories to the above letter.
Let me catch my breath, but I’ll be in touch.
Thank you soooooo much, Dr. John Whiting!!!!! Thank you!!!